One of the most controversial medical implants in recent years has been transvaginal mesh implants. Intended to treat pelvic organ prolapse and stress urinary incontinence, transvaginal mesh has been widely used since it was approved by the FDA in 2002. However, several years after FDA approval, reports of harm caused by the mesh implant began to emerge and transvaginal mesh lawsuits followed. Manufacturers have faced tens of thousands of mesh implant lawsuits with new transvaginal mesh lawsuit claims still being filed today. Defective medical device attorneys can help those who have been harmed by a transvaginal mesh device and litigate a transvaginal mesh claim for financial compensation for any harm that they have suffered.
UPDATE: Johnson & Johnson agreed to pay $117 million to settle allegations over the deceptive marketing of the mesh implant and failure to warn patients and doctors of the harmful risks.
Transvaginal Mesh Complications
Vaginal mesh implants have been linked with many dangerous side effects. Another type of mesh for hernias has been used since the 1950s but it has been alleged to shift in the patient’s body or cause infection, resulting in tens of thousands of lawsuits. Transvaginal mesh devices cause similar infection and experience similar shifting within the body, which can cause injuries and complications that are even more pronounced than experienced with hernia mesh devices.
Reports of possible vaginal mesh complications began to originate in the early part of the century. By 2008, there were nearly 1,000 reports of injuries caused by transvaginal mesh complications suffered by women who had received the mesh implant. This began to result in the public recognizing the issues caused by the mesh product and as a result, claims against the makers of these products.
Specifically, the report stated that pelvic mesh caused several different side effects and complications. Each of these vaginal mesh side effects is dangerous and can escalate into serious problems. Transvaginal mesh reports show the following side effects and injury in women:
- Transvaginal Mesh Erosion – After a period of time, the mesh degrades. This means that the mesh can fail, or the eroding mesh material can cause harm elsewhere in the body.
- Organ Perforation – The mesh can shift position. When it does that, it can come into contact with other organs and damage them to the point of perforation.
- Infection – The mesh is made out of material claimed to be inert, but in some instances, it can be the site of reactions
- Pain During Intercourse – The mesh can still be felt in the body
- Bleeding – The implant can irritate and rub against organs, causing bleeding.
Transvaginal Mesh Device Statistics
- During the period from 2005 to 2010, there were over 4,000 reports of complications arising from the use of transvaginal mesh devices.
- By 2008, the FDA released a statement warning of potential complications but asserted that these complications were rare.
- 75,000 transvaginal mesh surgeries were performed in 2010 and 10% of those implanted with the devices reported complications.
Estimated rates of transvaginal mesh complications from the procedure range from 10 percent to as high as 40 percent. Many of the vaginal mesh complications are debilitating and can cause lasting harm, but many of these side effects are not life-threatening. However, there were media reports in the United Kingdom about a woman who died from sepsis resulting from an infection caused by a transvaginal mesh implant. There were also reports of seven deaths between 2008 and 2010. By 2016, the FDA had changed its classification of transvaginal mesh to high-risk and recently on April 16th, 2019, the FDA halted all sales of Transvaginal Mesh Products.
Transvaginal Mesh Implant Procedure
During a transvaginal mesh procedure, the implant is inserted into the body through the vagina to support pelvic organs. There is a small incision made in the vaginal wall to accommodate the mesh. The transvaginal mesh is then affixed to the weakened or sagging organ through sutures or staples. The aim is for the mesh to shore up and provide support for the weakened organ.
While surgical mesh devices have been in use for decades, the use of them transvaginally only began in the 21st century. The FDA approved transvaginal mesh in 2002. After the initial approval, many manufacturers entered the market with their own transvaginal mesh system. Within a few years after approval, transvaginal mesh was used in nearly 100,000 surgeries annually. Five U.S. manufacturers, as well as European maker Coloplast, sold the device in the U.S.
The FDA Halts The Sale of Transvaginal Mesh
On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA’s decision states that the remaining companies in the marketplace have failed to demonstrate that the product is safe for long-term use. In this decision, the FDA stated that women who already had the product implanted did not need to have it removed, but should monitor for potential future injuries. According to the FDA, women should continue with annual checkups.
Surgical Mesh Lawsuit Settlements
Women who have been harmed by transvaginal mesh complications can file a lawsuit against the company that made the product. This is known as a product liability lawsuit. If successful, plaintiffs may receive the following:
- Compensation for pain and suffering
- Reimbursements for past and future medical bills
- Lost wages if surgical mesh complications caused missed work
- Loss of consortium
- Punitive damages against the manufacturer if there was an element of misconduct
As of January 2018, there have been approximately 73,000 product liability claims that have been filed against those who have manufactured or sold transvaginal mesh product. The number of pelvic mesh lawsuits continues to grow as more recipients of transvaginal mesh experience complications and injury. The statute of limitations begins from the time a recipient of the device knew or should have known that they were injured. It does not begin with the date that the mesh was implanted. As a result, those who have received the mesh, even many years ago, can still file suit so long as the injury did not occur until the applicable period of limitation. Given that this device is a figurative, “ticking time bomb” implanted in a woman’s body, it is likely that injuries will continue to occur and the number of vaginal mesh lawsuits will continue to increase in the future.
Surgical mesh lawsuits are categorized as product liability claims against the transvaginal mesh manufacturer. A vaginal mesh lawsuit will have to show that the product was defective in some way and that the plaintiff suffered harm from the transvaginal mesh. Transvaginal mesh product lawsuits have typically made the following claims:
- The product was defective and the manufacturer should be held liable for the harm suffered under all circumstances.
- Transvaginal mesh was defectively designed, causing it to either shift or degrade.
- The product was defectively manufactured, causing complications that women suffered.
- The makers of this product knew or should have known of the side effects, yet they failed to warn patients before they were implanted in their bodies.
- The defendants were negligent in designing and making the product.
- Transvaginal meshes violated warranties by not working for their intended purposes, which was to treat pelvic organ prolapse and stress urinary incontinence.
Transvaginal Mesh Settlements
Several of the manufacturers of this product elected to enter into a settlement of the claims that have been filed against them. Endo International plc, the company that purchased the original manufacturer of transvaginal mesh, settled the claims against transvaginal mesh for $2.6 billion. The company agreed to cease making and selling the product. Additionally, several other smaller manufacturers, including Coloplast, have settled their cases.
Some of the larger manufacturers have attempted to fight the cases brought against them in court. For example, Johnson & Johnson, who sells vaginal mesh products through its Ethicon subsidiary, sustained several large jury verdicts against it. Johnson & Johnson has settled thousands of cases against the mesh implant and has had jury verdicts as large as $35 million. Boston Scientific, another maker of transvaginal mesh products, had a $100 million verdict, which was later reduced to $10 million.
42 state Attorney Generals ordered J&J to pay $117 million settlement after allegations claiming the company deceptively marketed its mesh device and failed to warn consumers of the dangers linked to the device
Contact a Transvaginal Mesh Complications Lawyer
KBA Attorneys have experience in litigating cases where a defective medical device causes injury. These are cases that require the skill and knowledge of an attorney since they require analysis of scientific evidence and the likely testimony of expert witnesses. The manufacturers of these products facing tens of thousands of transvaginal mesh lawsuits will not simply admit liability and pay the full amount of the claim. If the defendants make a settlement offer, it will likely be on their terms, and a tough transvaginal mesh attorney is necessary to protect the plaintiff’s financial interests. Contact a transvaginal mesh attorney to learn about the signs and symptoms and to discuss your rights and to learn about the claims process in order to be as well-informed as possible. KBA Transvaginal Mesh Attorneys can help potential plaintiffs be in a position to react and respond quickly in the event they eventually experience symptoms or serious complications caused by transvaginal mesh.
- FDA. “Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA”, U.S. Department of Health and Human Services,https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/urogynecologic-surgical-mesh-implants-reporting-problems-fda. Accessed April 19, 2019.
- Mayo Clinic. “Get the facts about transvaginal mesh complications”, Mayo Foundation for Medical Education and Research, https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300. Accessed April 22, 2019.
- Hemendra N. Shah, Gopal H. Badlani. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424888/. Accessed April 22, 2019.
- Matthew Goldstein. “As Pelvic Mesh Settlements Near $8 Billion, Women Question Lawyers’ Fees”, The New York Times, https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed April 22, 2019.
- Department of Surgery, Division of Urology. “The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics”, Female Pelvic Medicine & Reconstructive Surgery, https://journals.lww.com/jpelvicsurgery/Abstract/2018/01000/The_Truth_Behind_Transvaginal_Mesh_Litigation__.4.aspx. Accessed April 22, 2019.
- Toyohiko Watanabe, MD, PhD and Michael B Chancellor, MD. “Pelvic Surgeons Caught in the Meshes of the Law”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3502050/. Accessed April 22, 2019.